Home GUDID 00849832002949 Leica Biosystems
Primary DI 00849832002949
Brand Leica Biosystems
Company Leica Biosystems Richmond, Inc.
Model 000000000003803100
Device description Frostbite
Published 2024-12-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name LEA PRESERVATIVE, CYTOLOGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LEA Preservative, Cytological Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10849832002946 Primary GS1 0 00849832002949 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10849832002946 10849832002946 00849832002949 00849832002949 849832002949 0849832002949
GMDN Terms# Term, Definition table Term Definition Histology tissue cassette IVD, laboratory processing, single-use A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 082930884 Device count 6 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 20849832016322 Leica Biosystems 3800081 3800081 2026-10-28 20849832016339 Leica Biosystems 3800082 3800082 2026-10-28 20849832016452 Leica Biosystems 3800083 3800083 2026-10-28 20849832023139 Leica Biosystems 3800080 3800080 2026-10-28 20849832023405 Leica Biosystems 3800085 3800085 2026-10-28 20849832023412 Leica Biosystems 3800086 3800086 2026-10-28 00849832004066 Leica Biosystems CytoVision DM5500 for FL-Ergo Head 23MIC550FXX009 2016-09-17 00849832007920 Leica Biosystems Ariol Fluorescent Unit 23AXCITEDM 2016-09-17 00849832007937 Leica Biosystems Ariol UPS 110V 23UPS2207 2016-09-17 00849832007944 Leica Biosystems Ariol UPS 220V 23UPS2208 2016-09-17 00849832009504 Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay 23MIC6004 2016-09-17 00849832009511 Leica Biosystems Ariol Leica DM6000B Ariol 23MIC6005 2016-09-17 00849832010333 Leica Biosystems Ariol DM6000 B Basic Configuration Ariol 23MIC1201 2016-09-17 00849832010340 Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished 23MIC1201R 2016-09-17 00849832010418 Leica Biosystems Ariol DM6000 B Ariol PL200 23MIC1206 2016-09-17 00849832010425 Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished 23MIC1206R 2016-09-17 00849832011361 Leica Biosystems Ariol Beveled Edge Slide Holder 23ASLSP016 2016-12-02 00849832011576 Leica Biosystems Ariol Cable, stage sensor 23ASLSP030 2017-03-29 00849832013204 Leica ADAPTOR C14 TO C7, POWER SUPPLY 23ADP0002 2017-10-13 00849832013228 Leica Biosystems Slide Cassettes, SL200 23ASLSP003 2017-11-17
Other Devices Sharing Product Codes#